DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The Amendment filed 18 Jun 2026 has been entered. Claims 1 and 3-8 are pending in the application with claim 2 canceled. Claims 1 and 3 are currently amended with claims 4-8 newly added. Applicant’s amendment to the Claims have overcome each and every 35 U.S.C. 112 rejection previously set forth in the Non-Final Office Action mailed 23 Mar 2026.
Response to Arguments
Applicant's arguments filed 18 Jun 2026 have been fully considered but they are not persuasive. Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. Applicant’s discussion of claim 1 is only found to feature discussion of the alleged benefits of the claimed invention without pointing to specific reasons why the cited prior art would fail to read on the claim (Pg. 6-8).
Claim Objections
Claim(s) 5 and 7-8 is/are objected to because of the following informalities:
Claim 5, Ln. 2 recites “the patient” which should read “a patient” as it is a first introduction
Claim 5 improperly ends with a comma
Claim 7, Ln. 2 recites “the inhaled air” which should read “inhaled air” as it is a first introduction
Claim 8, Ln. 2 recites “the inhaled air” which should read “inhaled air” as it is a first introduction
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 6-8 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 6 recites the limitation “detecting an air flow of inhaled air by the inhaled air sensor in the mask or the mouthpiece.” Claim 6 thus refers back to the inhaled air sensor of claim 1. However, the inhaled air sensor of claim 1 is “connected to the air purifier” and thus not at a suitable location to detect air flow “in the mask or the mouthpiece.” The claim thus appears to be attempting to define the inhaled air sensor as simultaneously at two different locations. The overall scope of the claim thus amounts to new matter not disclosed in the application as originally filed, with a single inhaled air sensor being located both “connected to the air purifier” and also detecting air flow “in the mask or the mouthpiece.”
Claim 7 recites the limitation “detecting an air pressure of the inhaled air by the inhaled air sensor in the mask or the mouthpiece.” Claim 7 thus refers back to the inhaled air sensor of claim 1. However, the inhaled air sensor of claim 1 is “connected to the air purifier” and thus not at a suitable location to detect air pressure “in the mask or the mouthpiece.” The claim thus appears to be attempting to define the inhaled air sensor as simultaneously at two different locations. The overall scope of the claim thus amounts to new matter not disclosed in the application as originally filed, with a single inhaled air sensor being located both “connected to the air purifier” and also detecting air pressure “in the mask or the mouthpiece.”
Claim 8 recites the limitation “detecting an air temperature of the inhaled air by the inhaled air sensor in the mask or the mouthpiece.” Claim 8 thus refers back to the inhaled air sensor of claim 1. However, the inhaled air sensor of claim 1 is “connected to the air purifier” and thus not at a suitable location to detect air temperature “in the mask or the mouthpiece.” The claim thus appears to be attempting to define the inhaled air sensor as simultaneously at two different locations. The overall scope of the claim thus amounts to new matter not disclosed in the application as originally filed, with a single inhaled air sensor being located both “connected to the air purifier” and also detecting air temperature “in the mask or the mouthpiece.”
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 1 and 3-8 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 1 recites the limitation “the drug fine particle generator being configured to be operated only when a sensing signal is input” in Ln. 18-20 which deems the claim indefinite. The language “when a sensing signal is input” is overly broad as it fails to identify where the sensing signal is coming from or how it is input. The sensing signal is recited in disconnection from other limitations of the claim which leads to confusion. Thus, the claim recites a function, i.e. a sensing signal, without clearing identifying the structure in the claim capable of performing the function (see MPEP 2173.05(g)). It is suggested to specify the source of the sensing signal, such as the inhaled air sensor recited earlier in the claim.
Claim 6 recites the limitation “detecting an air flow of inhaled air by the inhaled air sensor in the mask or the mouthpiece” which deems the claim indefinite. The inhaled air sensor of claim 1 is “connected to the air purifier” and thus not at a suitable location to detect air flow “in the mask or the mouthpiece.” It is thus unclear how applicant understands the (single) inhaled air sensor as located both “connected to the air purifier” and also detecting air flow “in the mask or the mouthpiece.”
Claim 7 recites the limitation “detecting an air pressure of the inhaled air by the inhaled air sensor in the mask or the mouthpiece” which deems the claim indefinite. The inhaled air sensor of claim 1 is “connected to the air purifier” and thus not at a suitable location to detect air pressure “in the mask or the mouthpiece.” It is thus unclear how applicant understands the (single) inhaled air sensor as located both “connected to the air purifier” and also detecting air pressure “in the mask or the mouthpiece.”
Claim 8 recites the limitation “detecting an air temperature of the inhaled air by the inhaled air sensor in the mask or the mouthpiece” which deems the claim indefinite. The inhaled air sensor of claim 1 is “connected to the air purifier” and thus not at a suitable location to detect air temperature “in the mask or the mouthpiece.” It is thus unclear how applicant understands the (single) inhaled air sensor as located both “connected to the air purifier” and also detecting air temperature “in the mask or the mouthpiece.”
Claim Interpretation - 35 USC § 112(f)
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “heating and humidifying apparatus being configured to generate second air by adjusting a temperature and a humidity of the first air” in claim 1 and “fine particle generating element” in claim 3.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The corresponding structure for the heating and humidifying apparatus is best understood from the specification as at least: heating and humidifying apparatus 3 in the form of a heating humidifier common in the art (e.g. Fig. 1).
The corresponding structure for the fine particle generating element is best understood from the specification as at least: fine particle generating element 34 which performs ultrasonic vibration (e.g. ¶¶25 & 27).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Montgomery (U.S. Pub. 2013/0014759) in view of Smaldone (U.S. Pub. 2021/0236750) and further in view of Parker et al. (U.S. Pub. 2007/0157931).
Regarding claim 1, Montgomery discloses an aerosol drug supply apparatus (Fig. 1; ¶0025) for a respirator (¶0025), the aerosol drug supply apparatus comprising: an air purifier (Fig. 1 #1; ¶0025) configured to discharge first air in which an oxygen concentration, a pressure, and a speed thereof are set (¶0028 – delivered air has some oxygen in it, positive pressure, air has some flow rate); a first tube (Fig. 1 between #1 and #4) along which the first air moves; a humidifying apparatus (Fig. 1 #4; ¶0025) connected to the first tube, the humidifying apparatus being configured to generate second air by a humidity of the first air (¶¶0025, 0037), and the humidifying apparatus being configured to discharge the second air; a second tube (Fig. 1 between #4 and #5) which is connected to the humidifying apparatus and along which the second air moves; a T-tube (Fig. 1 at #5) having a straight tube (Fig. 1 inline with inspiration flow) that has one side thereof provided with a branch tube (Fig. 1 to which nebulizer 5 is attached; ¶¶0025, 0036), the straight tube being directly connected to the second tube (Fig. 1), thereby allowing the second air to pass therethrough; a drug fine particle generator (Fig. 1 #5; ¶¶0025, 0036) mounted on the branch tube, the drug fine particle generator being configured to be operated only when a sensing signal is input (¶0025 – activation by patient inspiration requires a signal), and the drug fine particle generator being configured to spray a drug in a fine particle state to the second air (¶¶0035-0037); a Y-tube (Fig. 1 connecting inspiratory limb and expiratory limb to #6), the Y-tube having another side connected to a mask or a mouthpiece (¶0038 – endotracheal tubing is readable on a mouthpiece); and a return tube (Fig. 1 #3; ¶0025) having one side connected to the Y-tube (Fig. 1), the return tube having another side connected to the air purifier (Fig. 1), thereby allowing exhaled air to flow therethrough. It is noted that the “air purifier” is not expressly recited as either including any structure which performs purifying or as functionally performing any purifying of air. Thus, the term “purifier” is only understood as intended functionality and is given limited patentable weight (see MPEP 2114).
Montgomery fails to disclose an inhaled air sensor connected to the air purifier, the inhaled air sensor being configured to sense the first air. Montgomery fails to explicitly disclose the humidifying apparatus also performs heating; and the Y-tube having one side directly connected to the T-tube.
The illustration of Fig. 1 of Montgomery shows an additional piece of tubing between in-line nebulizer 5 and the wye piece, which means they are not “connected” in the illustration. However, Montgomery teaches it is preferred to locate the nebulizer proximate to the patient near the wye piece (¶0028). One of ordinary skill in the art would thus have considered it prima facie obvious to have specified in Montgomery the in-line nebulizer 5 as connected to the wye piece as fulfilling a preferred intention of Montgomery to locate the nebulizer as close to the patient as possible while still maintaining the nebulizer in a position upstream of the wye piece (e.g. ¶0028 and Fig. 1).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Montgomery the Y-tube having one side directly connected to the T-tube in order to provide the benefit of locate the drug fine particle generator (i.e. the nebulizer of Montgomery) as close to the patient as possible while still maintaining the drug fine particle generator in a position upstream of the Y-tube in view of the preference of this type of positioning as taught by Montgomery.
Smaldone teaches a ventilator circuit including a nebulizer (e.g. Figs. 1 & 5; ¶¶0034, 0048) including an inhaled air sensor (Figs. 1 & 5 #114; ¶0037) connected to a ventilator (Figs. 1 & 5 #102; ¶0037), the inhaled air sensor being configured to sense air exiting the ventilator and to generate a sensing signal (¶0037); and a nebulizer (Figs. 1 & 5 #101; ¶0037) being configured to be operated only when the sensing signal is input (¶0037 – nebulizer turned off when inhalation phase no longer detected). Smaldone teaches an inhaled air sensor controlling operation of a nebulizer as providing the benefit of synchronizing nebulizer delivery to only occur upon breath-actuation (¶¶0037-0039). It is additionally noted that Montgomery teaches a desire for the nebulizer to be activated by patient inspiration (¶0025).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Montgomery an inhaled air sensor connected to the air purifier, the inhaled air sensor being configured to sense the first air in order to provide the benefit of controlling operation of the drug fine particle generator (i.e. the nebulizer of Montgomery) to only delivery nebulized drug upon breath-actuation in view of Smaldone.
Parker teaches a ventilator circuit including a nebulizer (Fig. 2; ¶¶0077, 0080) and teaches the circuit used with a humidifier obviously controlled to provide heating to its humidified air (¶0170 – different temperatures of gases delivered). One of ordinary skill in the art would have obviously recognized that heating is a common function of humidifiers in the respiratory art as heating of the humidified gas helps ensure patient comfort by providing the humidified gas close to a normal physiological temperature.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have specified in Montgomery the humidifying apparatus also performs heating in order to provide the benefit of heating the humidified air to help ensure patient comfort by providing the humidified air close to a normal physiological temperature both in view of Parker and the common use of humidifiers in the respiratory art.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Montgomery (U.S. Pub. 2013/0014759) in view of Smaldone (U.S. Pub. 2021/0236750) and further in view of Parker et al. (U.S. Pub. 2007/0157931) and further in view of Porter et al. (U.S. Pub. 2018/0272081).
Regarding claim 4, Montgomery teaches the invention as modified above but fails to teach the sensing signal is a signal generated by a chest sensor, configured to be mounted on a patient's chest, and wherein the chest sensor is configured to detect when the patient's chest expands.
Porter teaches an aerosol delivery system (Fig. 2; ¶0031) including breath sensors (Fig. 2 #34; ¶0033) to control aerosol delivery based on a patient’s breath cycle (¶0033) which can take various forms, to include an impedance plethysmography sensor (Fig. 3 #40; ¶0035). One of ordinary skill in the art would recognize the impedance plethysmography sensor 40 of Fig. 3 as being a chest sensor which detects when the patient's chest expands. Porter thus teaches a chest sensor as an obvious design choice option of a breath sensor known in the art to be usable for controlling aerosol delivery based on a patient’s breath cycle.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in the modified Montgomery the sensing signal is a signal generated by a chest sensor, configured to be mounted on a patient's chest, and wherein the chest sensor is configured to detect when the patient's chest expands in order to provide the benefit of adding an additional form of breath sensor known in the art to be usable for controlling aerosol delivery based on a patient’s breath cycle in view of Porter.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Montgomery (U.S. Pub. 2013/0014759) in view of Smaldone (U.S. Pub. 2021/0236750) and further in view of Parker et al. (U.S. Pub. 2007/0157931) and further in view of Spandorfer (U.S. Pub. 2016/0136368).
Regarding claim 5, Montgomery teaches the invention as modified above but fails to teach the sensing signal is a specific brain wave signal generated when a patient is breathing.
Spandorfer teaches an automated aerosol drug dispensing system (Fig. 1; ¶¶0005, 0025) and teaches “smart” automated actuation of dispensing can be performed in response to a variety of patient physiological measures, to include EEG (¶0044). One of ordinary skill in the art would obviously recognize that EEG is used to monitor brain waves. Spandorfer thus teaches EEG, as a brain wave sensor, as an obvious design choice option of patient physiologic sensor known in the art to be usable for controlling automated actuation of aerosol delivery.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in the modified Montgomery the sensing signal is a specific brain wave signal generated when a patient is breathing in order to provide the benefit of adding an additional form of patient physiological measure known in the art to be usable for controlling automated actuation of aerosol delivery in view of Spandorfer.
Allowable Subject Matter
Claim 3 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim(s) 6-8 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 1st paragraph and 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 3, the claim remains allowed over the prior art for the same reasons discussed in the preceding Office action.
Regarding claims 6-8, Montgomery fails to teach or suggest the inhaled air sensor located both “connected to the air purifier” and also detecting air flow, pressure or temperature “in the mask or the mouthpiece.” Montgomery fails to locate its cited air purifier in a location which is at “the mask or the mouthpiece.” Note is made of the 35 U.S.C. 112(a) and U.S.C. 112(b) rejections of the claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH D BOECKER whose telephone number is (571)270-0376. The examiner can normally be reached M-F 9:00 AM - 4:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
Prosecution Insights